Lybalvi Approved for Schizophrenia, Bipolar I Disorder
The approval was based on data from 27 clinical studies, including the phase 3 ENLIGHTEN-1 and ENLIGHTEN-2 studies.
The approval was based on data from 27 clinical studies, including the phase 3 ENLIGHTEN-1 and ENLIGHTEN-2 studies.
Patients report side effects, beliefs, and knowledge about bipolar disorder are top reasons for not taking medications
In both trials, BXCL501 demonstrated statistically significant, rapid and durable improvements vs placebo across multiple agitation scales.
Women who initiated sleep medications rated their sleep disturbances similarly after 1 and 2 years.
The sNDA submissions are supported by data from 2 global randomized, double-blind, placebo-controlled phase 3 studies.
New guidelines on mask use; J&J vaccine update; Novel major depressive disorder treatment gains Priority Review; A scabies topical suspension; And a device to help stroke rehabilitation.
AXS-05 consists of dextromethorphan, an NMDA receptor antagonist, and bupropion, a norepinephrine and dopamine reuptake inhibitor.
No difference seen in change in depression scores at six weeks for psilocybin plus placebo versus psilocybin plus escitalopram
Estimated incidence of neurological or psychiatric diagnosis was 33.62 percent among 236,379 patients
Lamotrigine is indicated as monotherapy or adjunctive therapy for epilepsy and for use as maintenance treatment in patients with bipolar I disorder.